Scientists at Nelson Laboratories recently returned from presenting new in vitro research at the 2015 Society of Toxicology (SOT) annual meeting with news that the future of in vitro testing of medical devices in the United States looks bright, and closer than previously anticipated.

Invited to present information about their discovery of, and subsequent research on, an extractable positive control material for in vitro skin irritation testing of medical devices, this breakthrough may offer the data FDA has been waiting for.

Nelson Laboratories, along with strategic partners throughout the world, have been developing and validating this alternative in vitro skin irritation test method for a number of years. Skin irritation is a condition caused by acute damage to keratinocytes following exposure to a chemical. Testing for the skin irritation potential of medical devices has typically involved the use of laboratory animals.

While in vitro skin irritation test methods have historically been shown to provide results consistent with in vivo data, they have involved the use of chemical solutions or spiked extracts as positive controls. To provide a method that more accurately mimics in vivo medical device testing methods, in which devices are extracted in polar and non-polar solvents, in vitro research has been focused on discovering an extractable material that will induce a positive skin irritation response in both polar and non-polar extraction vehicles.

Nelson Laboratories’ discovery that heat-pressed polyvinyl chloride (PVC) sheets infused with Genapol X-080 act as an irritant in both polar and non-polar fluid is a major step forward toward regulatory acceptance of this method. Nelson Labs is working closely with regulators to usher in this new era of medical device testing.